DOSING
Convenient combination treatment taken orally once-daily1
Once-daily with or without food as a single tablet1
Bipolar I disorder in adults (manic or mixed episodes)1
Recommended starting dose
(olanzapine and samidorphan)
Monotherapy
10 mg/10 mg
![Tablet of LYBALVI 10 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-10.png)
or
15 mg/10 mg
![Tablet of LYBALVI 15 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-15.png)
Adjunct to lithium or valproate
10 mg/10 mg
![Tablet of LYBALVI 10 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-10.png)
Recommended dose
(olanzapine and samidorphan)
5 mg/10 mga
![Tablet of LYBALVI 5 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-5.png)
aOnly for bipolar I disorder maintenance monotherapy.
10 mg/10 mg
![Tablet of LYBALVI 10 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-10.png)
or
15 mg/10 mg
![Tablet of LYBALVI 15 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-15.png)
or
20 mg/10 mg
![Tablet of LYBALVI 20 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-20.png)
Tablets not shown at actual size.
Schizophrenia in adults1
Recommended starting dose
(olanzapine and samidorphan)
5 mg/10 mg
![Tablet of LYBALVI 5 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-5.png)
or
10 mg/10 mg
![Tablet of LYBALVI 10 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-10.png)
Recommended dose
(olanzapine and samidorphan)
10 mg/10 mg
![Tablet of LYBALVI 10 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-10.png)
or
15 mg/10 mg
![Tablet of LYBALVI 15 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-15.png)
or
20 mg/10 mg
![Tablet of LYBALVI 20 mg olanzapine / 10 mg samidorphan](/Content/images/pages/dosing/pill-20.png)
Tablets not shown at actual size.
- The dosage of samidorphan is fixed at 10 mg across all dosage forms1
- The maximum recommended dosage is 20 mg/10 mg once daily1
- Do not divide tablets or combine strengths1
Additional dosing considerations
Adjusting dosage1
- Dosage may be adjusted at weekly intervals of 5 mg (olanzapine component) depending upon clinical response and tolerability
- For bipolar I disorder monotherapy, dosage adjustments should occur at intervals of not less than 24 hours
- No dosage adjustment is needed for hepatic impairment or patients with mild, moderate, or severe renal impairment1
- Not recommended for end-stage renal disease
Dosage recommendations in specific populations1
- The recommended starting dosage is 5 mg/10 mg once daily in patients who have a higher risk of hypotensive reactions, are at risk of slower olanzapine metabolism, or may be more pharmacodynamically sensitive to olanzapine; if dose escalation is necessary, increase the dosage slowly in these patients
Please see LYBALVI Prescribing Information for additional dosing details.
![Actor portrayal of a patient](/Content/images/pages/dosing/dosing-actor-portrayal.png)
![Actor portrayal of a patient](/Content/images/pages/dosing/dosing-actor-portrayal-mobile.png)
Opioid use warning
LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal1
Precipitation of severe opioid withdrawal in patients who are physiologically dependent on opioids1
- Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short‑acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids
- Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers
Samidorphan, a component of LYBALVI, can precipitate severe opioid withdrawal in patients who are physiologically dependent on opioids1
- Administration may result in withdrawal syndrome severe enough to require hospitalization
Vulnerability to life-threatening opioid overdose1
- Attempting to overcome LYBALVI's opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication (eg, respiratory arrest, circulatory collapse)
- Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI
- Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased tolerance to opioids if LYBALVI therapy is interrupted or discontinued
- Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at previously tolerated dosages
In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia1:
- Discontinue LYBALVI,
- Opioids should be administered by individual(s) trained in the use of anesthetic drugs and the management of the respiratory effects of opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation, and
- Appropriately trained personnel should continuously monitor the patient in a setting equipped and staffed for cardiopulmonary resuscitation
In non-emergency situations, if a LYBALVI-treated patient is expected to require opioid treatment (eg, for analgesia during or after an elective surgical procedure)1:
- Discontinue LYBALVI at least 5 days before opioid treatment and
- Start olanzapine or another antipsychotic, if needed
Please see LYBALVI Prescribing Information for additional details on LYBALVI use and opioids.
![Actor portrayal of a patient](/Content/images/pages/dosing/dosing-actor-portrayal-2.png)
![Actor portrayal of a patient](/Content/images/pages/dosing/dosing-actor-portrayal-mobile-2.png)
LYBALVI Patient Counseling Tool
This resource is intended for use by healthcare providers to support counseling patients about opioid-related safety information for LYBALVI.
Download ToolPlease review the Medication Guide with your patients.
![Pose of bird in flight](/Content/images/general/desktop-bottom-bird.png)
Speak with a LYBALVI sales representative
Next:
Support & Savings for Patients
Reference: 1. LYBALVI [prescribing information]. Alkermes, Inc.